FDA product code NGA: Test, Follicle Stimulating Hormone (Fsh), Over The Counter
NGA is the FDA product code for test, follicle stimulating hormone (fsh), over the counter. It is a Class I device, regulated under 21 CFR 862.1300 and reviewed by the Clinical Toxicology panel. FDA has cleared 2 510(k) submissions under NGA, from 2 different applicants. The average 510(k) review took 184 days (median 184). FDA has posted 2 recalls for NGA devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Test, Follicle Stimulating Hormone (Fsh), Over The Counter |
| Device class | Class I |
| Regulation | 21 CFR 862.1300 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NGA clearance
Top NGA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Quantrx Biomedical Corporation | 1 | 2007-10-22 |
| Genosis, Inc. | 1 | 2003-10-30 |
Most recent NGA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K070484 | Quantrx Biomedical Corporation | QUANTRX FEMALE FERTILITY TEST | 2007-10-22 | 244 |
| K032002 | Genosis, Inc. | FERTELL FEMALE FERTILITY TEST | 2003-10-30 | 125 |
Recalls for NGA devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-11-22.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code NGA?
NGA is the FDA product code for test, follicle stimulating hormone (fsh), over the counter. It is a Class I device, regulated under 21 CFR 862.1300 and reviewed by the Clinical Toxicology panel.
What device class is NGA?
Class I, regulation 21 CFR 862.1300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NGA?
Across 2 cleared submissions the average was 184 days from receipt to decision (median 184).
Which companies have the most NGA clearances?
Quantrx Biomedical Corporation (1); Genosis, Inc. (1).
Have NGA devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-11-22.
Next steps
- Run an FDA pathway report with predicate devices for product code NGA
- Run a recall and safety report across every NGA manufacturer
- Watch product code NGA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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